US reviewing deaths of Tamiflu patients

US reviewing deaths of Tamiflu patients
Thu Nov 17, 2005 10:53 AM ET



WASHINGTON (Reuters) - U.S. regulators have asked Roche AG for more
information about the deaths of 12 children who took the flu-fighting
drug Tamiflu, saying in a report released on Thursday that the cause
of the deaths was "extremely difficult to interpret."

The Food and Drug Administration also said it was "concerning" that 32
psychiatric events, such as hallucinations and abnormal behavior, had
been reported in children who took Tamiflu, which is in high demand
because it is considered to be one of the best defenses against avian
flu in people.

Most of the reports came from Japan, the FDA said.

Roche, in a separate summary posted on the FDA Web site, said, "there
is no increase in deaths and neuropsychiatric events in patients on
Tamiflu versus influenza patients in general."